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Topical Applicator

by Sharn, Inc.

510(k) K070596

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK070596 Date21 Jun 2007ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0265-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2009
    • Terminated Z-0267-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2009
    • Terminated Z-0266-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2009

    Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CCT
Device Class
Class II
Regulation
21 CFR Part 868.5170
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Sharn, Inc.